La Jolla reports FDA's grant of breakthrough therapy designation for LJPC-0118
La Jolla Pharmaceutical Company announced that the US Food and Drug Administration has granted Breakthrough Therapy designation for the New Investigational Drug Product, LJPC-0118, for the treatment of severe malaria. "We are committed to the rapid development of LJPC-0118 to help patients suffering from severe malaria, a serious and life-threatening disease without a current FDA-approved therapy. We are very pleased to receive the Breakthrough Therapy designation from the FDA and are committed to providing LJPC-0118 to patients in the US," said George Tidmarsh, M.D., Ph.D., La Jolla's President and CEO. "This designation is a key regulatory milestone and we look forward to working closely with the FDA to further develop LJPC-0118." La Jolla plans to file a New Drug Application with the FDA in the fourth quarter of 2019 for LJPC-0118. The active pharmaceutical ingredient in LJPC-0118 was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies.